An observational study in Congenital Heart Disease, sponsored by French Cardiology Society. Active, not recruiting at 4 sites in France. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by French Cardiology Society · Observational
Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude.
The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are:
This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.
59 studies on the registry are indexed under Heart Septal Defects, Ventricular; 9 are open to participants now.
This study's enrollment of 218 is above the median of 100 across 25 observational studies indexed under Heart Septal Defects, Ventricular.
Browse Heart Septal Defects, Ventricular studies →French Cardiology Society is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
Compared within Heart Septal Defects, Ventricular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Defects, Congenital. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All consecutive patients who agreed to participate in the study, met the inclusion criteria, and treated in a French medical and surgical center with pediatric and congenital cardiology activity
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
It is an observational study, no intervention or examination will be realized for the sole purpose of the study. Patient management will be at the discretion of referral cardiologists according to the practices of the centers. As part of the usual follow-up of these patients, the participating centers collect the clinical and echocardiography data from inclusion and the following year, as well as data from a functional assessment at baseline and at one year. and the collection of cardiovascular events at 5 years and 10 years of follow-up. Data from a possible percutaneous or surgical closure procedure will be collected. The indication of VSD closure will be left to the discretion of participating centers. There will be no recommendation for percutaneous or surgical closure of VSD for the sole purpose of this observatory.
Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload
The main criterion "cardiovascular event" is a composite criterion. At least 1 of the following criteria is required for the primary criterion to be met: * endocarditis, * aortic stenosis (mean gradient\> 20 mmHg) * aortic insufficiency * left ventricular outflow tract stenosis (mean gradient\> 20 mmHg) * tricuspid insufficiency ≥2 * surgery or cardiac interventional catheterization for an abnormality in relation to the VSD (other than simple closing) * persistent supraventricular arrhythmias, sustained ventricular arrhythmia, * stroke * Complete atrioventricular block (AVB) * Pulmonary Arterial Hypertension (PAH) * heart failure * cardiovascular deaths, * severe haemolysis (= requiring transfusion or interventional catheterization or surgical).
Time frame: 5 years of follow-up
Anatomical predictive elements of events at 5 years of follow-up.
The event criterion meets the same definition as the primary judgment criterion. The association between anatomical elements (size of the VSD, presence of aneurysm, diameter and depth of the aneurysm, septo-aortic angulation) and cardiovascular events will be studied.
Time frame: 5 years of follow-up
Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure
Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure
Time frame: 1 year of follow-up
Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 5 years of follow-up
Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options (medical - percutaneous closure - surgical closure) at 5 years of follow-up. The event criterion meets the same definition as the primary judgment criterion.
Time frame: 5 years of follow-up
Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 10 years of follow-up.
Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options (medical - percutaneous closure - surgical closure) at 10 years of follow-up. The event criterion meets the same definition as the primary judgment criterion.
Time frame: 10 years of follow-up
Plan to share: No
Ran from Jun 2018 to primary completion in Dec 2021, 42 months.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Heart Septal Defects, Ventricular →
French Cardiology Society